Clinical Trials/NCT06681493

NCT06681493

Completed

Phase 1

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and PK/PD of YZJ-4729 Tartrate Injection After A Single Ascending Dose

Shanghai Haiyan Pharmaceutical Technology Co., Ltd.1 site in 1 country66 target enrollmentOctober 12, 2022

ConditionsPostoperative Analgesia

InterventionsYZJ-4729 Tartrate injection YZJ-4729 simulated injection

DrugsYZJ-4729 Tartrate injection YZJ-4729 simulated injection

Overview

Phase: Phase 1
Intervention: YZJ-4729 Tartrate injection
Conditions: Postoperative Analgesia
Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Enrollment: 66
Locations: 1
Primary Endpoint: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Part A

Primary objective:

• To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection.

Secondary objectives:

To investigate the PK/PD profile of YZJ-4729 tartrate injection administered as a single dose;
To investigate the metabolic transformation characteristics of YZJ-4729 tartrate;
To assess the relationship between plasma concentrations and change in QT interval (C-QT) and the effect on QT interval in subjects after a single dose of YZJ-4729 tartrate injection.

Part B

Primary objective:

• To evaluate the safety, tolerability and pharmacokinetic profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates .

Secondary objectives:

• To investigate the PK/PD profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates.

Registry

clinicaltrials.gov

Start Date

October 12, 2022

End Date

September 22, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects aged between 18 and 45 years (inclusive) on the day of signing the informed consent;
•Male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg. Body mass index within the range 19.0-26.0 kg/m 2 (inclusive);
•Subjects in good health without a history of serious diseases and chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system and mental system;
•From the date of signing the informed consent form until 6 months after the last dose of investigational drug, the subject (including partner) need to have no sperm or egg donation plan or pregnancy plan and voluntarily take effective contraceptive measures.
•Voluntarily need to sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.

Exclusion Criteria

•Medical history of cardiovascular and respiratory system (such as sleep apnea syndrome, pulmonary heart disease or chronic bronchial asthma), liver, kidney, nervous system (such as epilepsy), blood system or mental disorders that the researcher considers clinically significant;
•Medical history of cardiovascular system disease, including but not limited to history or family history of syncope, coronary heart disease (such as coronary angiography diagnosis of coronary heart disease, history of acute coronary syndrome, history of myocardial infarction, etc.), valvular heart disease, heart failure, history of non-drug-induced bradyarrhythmia, frequent ventricular premature beats, ventricular tachycardia, etc.; or previous QTc prolongation or other risk factors for torsades de pointes (hypokalemia, etc.), or a family history of a first-degree relative (i.e., biological parent, brother, sister or child) with short QT syndrome, long QT syndrome, sudden death of unknown cause in his youth (less than/equal to 40 years old), drowning or sudden infant death syndrome;
•Medical history of symptomatic head trauma;
•History of frequent nausea or vomiting of any etiology;
•Medical history of glaucoma or any condition affecting pupil size;
•Major surgery or major trauma within 6 months prior to screening or planning to undergo surgery during the study;
•Known to be allergic to two or more kinds of food and drugs;
•Known to be allergic to opioids, or have contraindications for the use of such drugs;
•Difficulties in collecting venous blood, or the cases with known needle and blood sickness history;
•Female subjects who are lactating, pregnant, preparing for pregnancy or have the abnormal pregnancy test results with clinical significance at screening;

Arms & Interventions

Part A

Part A Experimental: YZJ-4729 Tartrate injection; Part A Control: YZJ-4729 simulated injection

Intervention: YZJ-4729 Tartrate injection

Part A

Part A Experimental: YZJ-4729 Tartrate injection; Part A Control: YZJ-4729 simulated injection

Intervention: YZJ-4729 simulated injection

Part B

Subjects will receive YZJ-4729 Tartrate injection

Intervention: YZJ-4729 Tartrate injection

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Time Frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17

Incidence of participants with clinical laboratory abnormalities

Time Frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17

Incidence of participants with vital signs abnormalities

Time Frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17

Incidence of participants with physical exam abnormalities

Time Frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17

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